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Sonendo®, Inc., the developer of a transformative technology for the endodontic marketplace, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the third generation of its Multisonic UltracleaningTM System for root canal therapy. This recent 510(k) clearance expands the use for the GentleWaveTM System to include anterior and pre-molar cases in addition to the current molar indication. The system is designed to be a minimally-invasive, disruptive technology that utilizes multiple wavelengths of sound to clean the entire root canal system simultaneously.

“We are excited about the FDA clearance that gives Sonendo the right to market the system within the United States. Sonendo plans a phased launch of its third generation GentleWaveTM system in 2015,” noted Bjarne Bergheim, President and Chief Executive Officer.

“I have been amazed at the results I have seen thanks to the GentleWaveTM system. At the end of every case, I can’t wait to take the final radiograph to see what unusual anatomy I have been able to clean and obturate. What’s even more amazing is that I am able to clean and fill multiple accessory canals while minimally shaping the canals and preparing a minimal access opening. The result is endodontics that is more fun, predictable, and successful!” said Tyler F. Baker, DDS, MS, of San Marcos, CA.

The company’s 510(k) clearance is released through the FDA’s Center for Devices and Radiological Health (CDRH).

The latest generation of the GentleWaveTM system will debut this week at the American Academy of Endodontics annual meeting scheduled for May 6-9, 2015 at the Washington State Convention Center located in Seattle, WA.